FDA.reportPublic FDA data

Diclofenac Sodium

Product NDC
42291-230
11-digit product format
422910230
Labeler code
42291
Product ID
42291-230_485b95c5-2a91-3aa3-e063-6394a90a10d7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
AvKARE
Application
ANDA075185
Marketing category
ANDA
Marketing start
2011-03-17
Substance
DICLOFENAC SODIUM
Active strength
50 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Diclofenac Sodium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DICLOFENAC SODIUM50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQTG126297Q
Rxcui855906, 855926

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
111d457e-3138-4512-b0ba-d0cd760c4055Product name320250225
0426261e-1bb9-b78b-abd2-80da765a7e3eProduct name220240513
7b6158ae-c3f4-3d73-c35f-6f5d18b9efd7Product name520240320
0ac2f11f-f58d-baf2-71a0-680993b48a61Product name220231211
855d63c3-b090-4636-8fc7-6d39ad23c44fProduct name120230829
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
bb58f410-04be-65dd-9211-e89ead899698Product name620230323
0fcbc38a-8b29-3348-1cef-5222ea53484fProduct name420220516
c4e1eedc-aca2-4551-8382-89144ed9d049Product name320220126
8d368a34-1453-43ea-828d-0dbcd72b8794Product name820210622
d6bab9d2-edce-a213-4796-226ab15472c3Product name620200616
2487e6ef-d419-42fc-aaf8-7acc805d2370Product name220170718
e071c814-e5e7-e7ed-ec76-428765d9c66bProduct name220151120
93148e06-b8d7-4e6c-853e-62f807d17fbbProduct name120151014
dbb00be6-fb1c-4b0a-a770-31f7e05e247eProduct name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42291-230-10Diclofenac Sodium1000 in 1 BOTTLETABLET, DELAYED RELEASE100017
42291-230-18Diclofenac Sodium180 in 1 BOTTLETABLET, DELAYED RELEASE18017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-230-10EA - Each42291-230489fffb4-42bd-4d88-b85b-2588fa4ba98012012-07-24
42291-230-18EA - Each42291-2308c7fb421-3944-4e78-b316-898ad34cd89a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Diclofenac SodiumACTIVE INGREDIENTQTG126297QDICLOFENAC SODIUM TABLET, DELAYED RELEASE [AVKARE, INC.]10
DiclofenacACTIVE MOIETY144O8QL0L1DICLOFENAC SODIUM TABLET, DELAYED RELEASE [AVKARE, INC.]10
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDICLOFENAC SODIUM TABLET, DELAYED RELEASE [AVKARE, INC.]10
Ferrosoferric OxideINACTIVE INGREDIENTXM0M87F357DICLOFENAC SODIUM TABLET, DELAYED RELEASE [AVKARE, INC.]10
hypromellosesINACTIVE INGREDIENT3NXW29V3WODICLOFENAC SODIUM TABLET, DELAYED RELEASE [AVKARE, INC.]10
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDICLOFENAC SODIUM TABLET, DELAYED RELEASE [AVKARE, INC.]10
magnesium stearateINACTIVE INGREDIENT70097M6I30DICLOFENAC SODIUM TABLET, DELAYED RELEASE [AVKARE, INC.]10
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JDICLOFENAC SODIUM TABLET, DELAYED RELEASE [AVKARE, INC.]10
Polyethylene GlycolsINACTIVE INGREDIENT3WJQ0SDW1ADICLOFENAC SODIUM TABLET, DELAYED RELEASE [AVKARE, INC.]10
PovidonesINACTIVE INGREDIENTFZ989GH94EDICLOFENAC SODIUM TABLET, DELAYED RELEASE [AVKARE, INC.]10
ShellacINACTIVE INGREDIENT46N107B71ODICLOFENAC SODIUM TABLET, DELAYED RELEASE [AVKARE, INC.]10
Sodium Starch Glycolate Type A PotatoINACTIVE INGREDIENT5856J3G2A2DICLOFENAC SODIUM TABLET, DELAYED RELEASE [AVKARE, INC.]10
talcINACTIVE INGREDIENT7SEV7J4R1UDICLOFENAC SODIUM TABLET, DELAYED RELEASE [AVKARE, INC.]10
Titanium dioxideINACTIVE INGREDIENT15FIX9V2JPDICLOFENAC SODIUM TABLET, DELAYED RELEASE [AVKARE, INC.]10
Triethyl CitrateINACTIVE INGREDIENT8Z96QXD6UMDICLOFENAC SODIUM TABLET, DELAYED RELEASE [AVKARE, INC.]10
Diclofenac SodiumACTIVE INGREDIENTQTG126297QDICLOFENAC SODIUM TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
DiclofenacACTIVE MOIETY144O8QL0L1DICLOFENAC SODIUM TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDICLOFENAC SODIUM TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
Ferrosoferric OxideINACTIVE INGREDIENTXM0M87F357DICLOFENAC SODIUM TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
hypromellosesINACTIVE INGREDIENT3NXW29V3WODICLOFENAC SODIUM TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDICLOFENAC SODIUM TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
magnesium stearateINACTIVE INGREDIENT70097M6I30DICLOFENAC SODIUM TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JDICLOFENAC SODIUM TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
Polyethylene GlycolsINACTIVE INGREDIENT3WJQ0SDW1ADICLOFENAC SODIUM TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
povidoneINACTIVE INGREDIENTFZ989GH94EDICLOFENAC SODIUM TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
ShellacINACTIVE INGREDIENT46N107B71ODICLOFENAC SODIUM TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
Sodium Starch Glycolate Type A PotatoINACTIVE INGREDIENT5856J3G2A2DICLOFENAC SODIUM TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
talcINACTIVE INGREDIENT7SEV7J4R1UDICLOFENAC SODIUM TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
Titanium dioxideINACTIVE INGREDIENT15FIX9V2JPDICLOFENAC SODIUM TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
Triethyl CitrateINACTIVE INGREDIENT8Z96QXD6UMDICLOFENAC SODIUM TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42291-230DICLOFENAC SODIUM TABLET, DELAYED RELEASE [AVKARE]16Current NDC, Legacy NDC, 2 package rows20240104_19b4ff5c-adb7-a0d0-7ef2-4ae05047fd94.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855906diclofenac sodium 50 MG Delayed Release Oral TabletPSN19b4ff5c-adb7-a0d0-7ef2-4ae05047fd9417
855926diclofenac sodium 75 MG Delayed Release Oral TabletPSN19b4ff5c-adb7-a0d0-7ef2-4ae05047fd9417
855906diclofenac sodium 50 MG Delayed Release Oral TabletSCD19b4ff5c-adb7-a0d0-7ef2-4ae05047fd9417
855926diclofenac sodium 75 MG Delayed Release Oral TabletSCD19b4ff5c-adb7-a0d0-7ef2-4ae05047fd9417
855906diclofenac sodium 50 MG Delayed Release Oral TabletPSN0c4281ab-1cd8-4e45-904c-9b9f5940c3bb1
855906diclofenac sodium 50 MG Delayed Release Oral TabletSCD0c4281ab-1cd8-4e45-904c-9b9f5940c3bb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42291-230-10422910230101000 TABLET, DELAYED RELEASE in 1 BOTTLE (42291-230-10) 2011-09-220000-00-00NoNoCurrent
42291-230-1842291023018180 TABLET, DELAYED RELEASE in 1 BOTTLE (42291-230-18) 2011-03-170000-00-00NoNoCurrent